DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
DISSECT-N is a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
Study Type
OBSERVATIONAL
Enrollment
102
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Composite safety and effectiveness
Safety: Major Adverse Events (MAEs) Defined as: all-cause mortality (ACM), retrograde type A dissection (RTAD), aortic rupture, permanent paraplegia and paraparesis, stent induced new entry tear, conversion to open repair, disabling stroke, and non-preexisting renal failure. Effectiveness: Technical success defined as ability to advance, deploy and position the Valiant Navion Thoracic Stent Graft at target site with successful coverage and sealing of the proximal entry tear and removal of the delivery system. The primary endpoint is a dichotomous study outcome and a composite endpoint. A subject who has technical success and no MAE reported within 1-month will be considered a success.
Time frame: 1-month post index procedure
Aortic remodeling
Rate of aortic remodeling based on follow-up imaging.
Time frame: 1-month, 1, 2 and 3 years
Access related complications
Rate of access related complications as proportion of evaluable patients.
Time frame: peri-operative
Stent induced entry tear
Rate of stent induced entry tear as proportion of evaluable patients.
Time frame: 1, 2 and 3 years
Stent graft migration
Rate of stent graft migration (\>10mm) as proportion of evaluable patients.
Time frame: 1, 2 and 3 years
Stent graft integrity
Rate of each type of loss of stent graft integrity (kink, twist, fracture, occlusion, or stenosis) as a proportion of evaluable patients based on follow-up imaging.
Time frame: 1-month, 1, 2 and 3 years
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University of Florida Health Shands Hospital
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States
Albany Medical Center
Albany, New York, United States
Northwell Health Lenox Hill Hospital
New York, New York, United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
...and 12 more locations
Disease progression
Extension of dissection.
Time frame: 1,2 and 3 years
Transient Ischemic Attack (TIA)/minor strokes
Rate of TIA/minor stroke as a proportion of evaluable patients.
Time frame: 1-month
Transient spinal cord ischemia
Rate of transient spinal cord ischemia as a proportion of evaluable patients.
Time frame: 1-month, 1, 2 and 3 years
Unplanned secondary procedures
Rate of unplanned secondary procedures.
Time frame: 1, 2 and 3 years
False lumen perfusion
Rate of each type of false lumen perfusion based on follow-up imaging.
Time frame: 1-month, 1, 2 and 3 years
Endoleaks
Rate of each type of endoleak based on follow-up imaging.
Time frame: 1-month, 1, 2 and 3 years
Major adverse events
Major adverse events defined as: * All-cause mortality (ACM) * Retrograde type A dissection (RTAD) * Aortic rupture * Permanent paraplegia and paraparesis * Stent induced new entry tear * Conversation to open repair * Disabling stroke * Non-preexisting renal failure
Time frame: 1, 2 and 3 years